BRPI0515759B1 - NEEDLE NEEDLE INJECTION DEVICE AND KIT FOR USE - Google Patents

Abstract

"injector without needle". The present invention relates to a needleless injection device for applying a drug under pressure to an animal or human. the injection device includes an actuation device comprising: a gas-tight chamber; a piston and rod assembly slidably received within the chamber and movable between a forward position and a rear position; a gas charge within the chamber to force the piston and rod assembly to the forward position; a means for moving said piston and rod assembly said gas charge to the rear position; and a trigger for releasably holding the piston and rod assembly in the rear position. Also provided is a method and kit for using the device to deliver a liquid through the skin of an animal or human.

Description

(54) Title: INJECTION DEVICE WITHOUT NEEDLE AND KIT FOR USE OF THE SAME (51) Int.CI .: A61M 5/30 (30) Unionist Priority: 01/12/2004 US 60 / 632,316 (73) Holder (s) : ACUSHOT INC.

(72) Inventor (s): WARREN L. TOLES; KEVIN TOLES; JULES POIRON

1/39

Descriptive Report of the Invention Patent for INJECTION DEVICE WITHOUT NEEDLE AND KIT FOR USE OF THE

SAME.

Field of the Invention [001] The present invention belongs to the field of needle-less injectors.

Background of the Invention [002] Injections of medications are typically performed using injectors that contain a needle. There are a variety of problems associated with needle-containing injectors including the cross-contamination of subjects receiving an injection, the pain associated with such injections and the potential for the needle to break, and to dislodge, within a subject being injected. The breaking of a needle inside a subject can not only be detrimental to the subject's health and well-being, but can also have a significant economic impact.

[003] Increasingly, efforts have been directed towards the development of injectors without a needle, in an attempt to avoid the problems associated with injectors containing a needle in current use. Typically, such needleless injectors are powered by an external gas supply in order to provide sufficient energy to drive the liquid through the skin. The need for an external gas supply can be disadvantageous to the user, as it can be cumbersome and not accessible for use within an environment such as an office, laboratory, farm or similar. It may also be inconvenient to store these types of external power supplies. In addition, previous needle-less injectors are typically complicated in design, which in turn results in increased manufacturing costs.

[004] There is still a need, therefore, for injectors

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2/39 without improved needle.

[005] This background information is provided for the purpose of making known the information that the applicant believes is of possible relevance to the present invention. No admission is necessarily intended, nor should it be considered, that any of the foregoing information constitutes the prior art in relation to the present invention.

Summary of the Invention [006] An object of the present invention is to provide a needle-free injection device. According to one aspect of the present invention, a needle-free injection device is provided to deliver a medicament under pressure from a dosage reservoir through an outlet for administration to an animal and / or human, of the type comprising a plunger received sliding into said dosing reservoir and movable in a forward direction to expel said medicine through said orifice, the improvement comprising an actuation device arranged on said needle-free injection device, said actuation device comprising: a chamber gas-tight; a piston and rod assembly received sliding inside the chamber and movable between a front position and a rear position; a gas charge inside the chamber to force the piston and rod assembly to the front position; a means for moving the piston and rod assembly against the gas charge to the rear position; and a trigger to retain the piston and rod assembly releasable in the rear position, whereby activation of the trigger causes the piston and rod assembly to be released for movement by the gas charge to the front position in order to impact the plunger, directly or indirectly, with sufficient force to cause the plunger to move in the forward direction to expel the medicine through that outlet.

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3/39 [007] According to an embodiment of the present invention the piston circumference of said piston and rod assembly defines an outer edge that is in contact with the internal surface of said gas-tight chamber so that the piston defines a extension portion and a compression portion of said gas-tight chamber.

[008] According to another embodiment of the present invention, the needleless device comprises a clearance coupling that connects the piston assembly rod and piston rod, wherein said clearance coupling is configured to maintain a clearance distance between the said rod and said piston when said piston and rod assembly is in said rear position. Preferably, the clearance coupling comprises a first end for removable attachment of the clearance coupling to said rod; and a second end for sliding coupling with the plunger.

[009] In accordance with a specific embodiment of the present invention, the device includes a manual means for moving the piston and rod assembly against the gas charge, which comprises: (a) an articulated connected handle on said needle-free injection device and pivotable from a first closed position to a second open position; (b) a thrust rod attached to the said handle; and (c) an actuating member operatively associated with the rod of said piston and rod assembly and configured to move in response to coupling with the push rod, whereby when said handle is moved from said first closed position to said second position, said push rod engages said actuating member and when said handle is returned to said closed position, a push force is transferred to said push rod, which in turn transPetition 870170056992, 09 / 08/2017, p. 10/55

4/39 injects the driving force for said actuating member to move said piston and rod assembly from said front position to said rear position.

[0010] According to an alternative embodiment of the present invention, the manual means comprises a connected handle articulated in said needle-free injection device and articulated from a first closed position to a second open position; an actuating member operatively associated with the rod of said piston and rod assembly; and a force transfer means for transferring the force applied on the handle to a set of gears operatively associated with said handle, whereby when said handle is moved from said first closed position to said second open position said set of gears transfers the force generated by the movement of the handle to said actuating member to move said piston and rod assembly from said front position to said rear position.

[0011] Alternatively, the means for moving said piston and rod assembly is a motorized means, for example a DC or AC power source.

[0012] According to another embodiment of the present invention, the needle-free injection device further comprises a set of gears driven by a motor; and an actuating member operatively associated with the rod of said piston and rod assembly, whereby said engine transfers a force to said gear set, which transfers the force to said actuating member to move said rod piston and rod assembly from said front position to said rear position.

[0013] According to another specific embodiment of the present invention, the trigger comprises a firing lever having a first end and a second end and being pivotable

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5/39 around a hinge member and connected at said first end of said push rod, whereby when a downward force is exerted on said second end of said firing lever it hinges around said member pivoting rod and said first end is raised causing said driving rod to disengage from said actuating member so that said piston and rod assembly moves from said rear position to said front position. [0014] In accordance with another aspect of the present invention, a method is provided for injecting a drug into an animal / human, which comprises: (a) providing a needle-free injection device as described herein and which has a drug within said dosing chamber; (b) placing the exit orifice of the injection device against said animal in a location for administration; and (c) firing said injection device so that said medicine is expelled through said outlet.

[0015] In accordance with another aspect of the present invention, a kit is provided for using a needle-free injection device as described herein, which comprises: (a) the needle-free injection device; and (b) instructions for its use.

Brief Description of the Figures [0016] Figure 1A is a photograph of a needle-free injection device according to one embodiment of the present invention and Figure 1B is a photograph of a needle-free injection device according to another embodiment of the present invention;

[0017] Figure 2 is a cross-sectional view of a needle-free injection device according to an embodiment of the present invention;

[0018] Figure 3 provides three cross-sectional views of an actuation device in three stages of operation of an

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6/39 needle-free injection according to another embodiment of the present invention. Figure 3A shows the actuation device before being mounted inside the needle-free injection device housing. Figure 3B shows the actuation device mounted inside the needle-free injection device housing, where the actuation device is in an unloaded condition. Figure 3C shows the same actuation device as shown in Figure 3B after the user has loaded the device, so that the piston and rod assembly is in the rear position;

[0019] Figure 4 is a cross-sectional view of a clearance coupling suitable for use in a needle-free injection device according to another embodiment of the present invention. Figure 4A shows an exploded view of the plunger, clearance coupling and connector. Figures 4B and 4C show the piston received sliding inside the clearance coupling, the clearance coupling is attached to the connector, which is in turn connected to the rod;

[0020] Figure 5 is a cross-sectional view of a manual means for moving the piston and rod assembly against the gas charge in a needle-free injection device according to an embodiment of the present invention. Figures 5A and 5B show the handle in the first closed position and in the second open position, respectively;

[0021] Figure 6 is a photograph of an example of the manual loader shown in Figure 5;

[0022] Figure 7 is a photograph of an example of the manual loader shown in Figure 5;

[0023] Figures 8A and B are a cross-sectional view of a needle-free injection device (A) and a manual unit (B) according to an embodiment of the present invention;

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7/39 [0024] Figure 9 is a cross-sectional view of a needleless injection device according to an embodiment of the present invention;

[0025] Figure 10 is a graphical representation of the pressure pattern observed after firing the injection device of the present invention;

[0026] Figure 11 is a side view of an embodiment of the needleless injector of the present invention;

[0027] Figure 12 is a cross-sectional side view of the needle-less injection device shown in Figure 11;

[0028] Figure 13 is a partial perspective view of the needleless injection device shown in Figure 11;

[0029] Figure 14 is a partial perspective view of the needleless injection device shown in Figure 11;

[0030] Figure 15 is a partial perspective view of the needleless injection device shown in Figure 11;

[0031] Figure 16 is a perspective view, partially exploded, of the needleless injection device shown in Figure 11; [0032] Figure 17 is a side view, partially exploded, of the needleless injection device shown in Figure 11;

[0033] Figure 18 is a perspective view, partially exploded, of the needleless injection device shown in Figure 11; [0034] Figure 19 is a side view, partially exploded, of the needleless injection device shown in Figure 11;

[0035] Figure 20 is a longitudinal cross-sectional view of the needle-free injection device shown in Figure 11;

[0036] Figure 21 is a partial perspective view of the needleless injection device shown in Figure 11;

[0037] Figure 22 is a partially transparent side view of a needleless injection device according to an embodiment

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8/39 alternative of the present invention;

[0038] Figure 23 is a side view of the needleless injection device shown in Figure 22;

[0039] Figure 24 is an enlarged side view of the needleless injection device shown in Figure 22; and [0040] Figure 25 is an enlarged side view of the needleless injection device shown in Figure 22.

[0041] In the Detailed Description that follows the numbers in bold type, they serve to identify the component parts that are described and referred to in relation to the drawings that present various modalities of the invention. It should be noted that in describing the various embodiments of the present invention, the same reference numbers have been used to identify the same or similar elements. Furthermore, for the sake of simplicity, parts have been omitted from some figures in the drawings.

Detailed Description of the Invention [0042] As will be explained in more detail below, the present invention provides a needle-free injection device for injecting a drug under pressure into a human or an animal. The device of the present invention comprises some of the features of standard needle-free injection devices that include a dosage reservoir for the medicament, and an outlet port in the dosing reservoir through which the medicament is expelled for administration to animals or humans. As with certain needle-free injection devices known in the art, the device of the present invention makes use of a plunger received sliding into the dosing reservoir and movable forward to expel the drug through the outlet port. In the device of the present invention, these characteristics are combined with an actuation device comprising a gas-tight chamber that has a set

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9/39 piston and rod received sliding in it, a gas charge inside the gas-tight chamber to force the piston and rod assembly to a forward position, a means for moving the piston and rod assembly against the gas charge to a rear position and a trigger to retain the piston and rod assembly releasable in the rear position, so that when the trigger is released, the piston and rod assembly moves to the front position to impact the piston directly or indirectly, with sufficient force to move the plunger forward to expel the medication from the dosing reservoir and through the skin of the human or animal being treated.

[0043] All or a portion of the needle-free injection device is preferably sized to be portable, for example manual, thereby allowing a user to move from subject to subject (for example, a human or an animal) to perform injections. Alternatively, all or a portion of the needleless injection device can be permanently or removably attached to a structure, such as an injection station, thereby allowing the user to bring subjects to the injection station to receive an injection. In certain applications it may also be beneficial to have only the dosage portion of the device sized to be manual for a user. In this modality, the actuation portion remains operatively associated with the dosage portion. [0044] Referring to Figures 1-10, the needle-free injection device comprises a dosage reservoir 16 for receiving a liquid, such as a medicament. Reservoir 16 has a discharge end that has an outlet orifice that has a nozzle 17, through which the liquid within the reservoir can be shipped for administration to an animal or a human. Optionally, the nozzle 17 is removably attached to the discharge end of the reservoirPetition 870170056992, from 08/09/2017, pg. 16/55

10/39 dosing ratio 16, for example via thread mounting. Optionally, reservoir 16 has an inlet opening through which liquid can be received. The metering reservoir 16 can be sized to accommodate a range of liquid volumes. In addition, the dosage reservoir 16 can be removable in order to facilitate the use of reservoirs of varying sizes and / or materials suitable for different volumes or different liquids depending on the specific applications.

[0045] Generally opposite the discharge end of the metering reservoir is an expulsion means for expelling liquid within the metering reservoir through the outlet port. In an embodiment of the present invention, as seen in Figure 2, the expulsion means is a piston 15 received sliding into the metering reservoir 16 and movable between a rear position and a front position. The plunger 15 is dimensioned to mount inside the metering reservoir 16 so that when it is moved from the rear to the forward position it causes the liquid inside the metering reservoir 16 to be expelled. The movement of the piston 15 from the rear to the front position is controlled by an actuation device 40.

[0046] The actuation device 40 is arranged inside a housing 1 of the needle-free injection device. The components of the actuation device 40 are typically formed of a durable material, non-limiting examples of which include, steel, stainless steel and / or an alloy. The components of the needle-free injection device are typically formed of a durable material, non-limiting examples of which include, steel, stainless steel, an alloy, carbon fiber and / or a composite plastic.

[0047] In accordance with an embodiment of this invention, housing 1 is adapted to be safe by a user, and option 870170056992, from 08/09/2017, p. 17/55

11/39 finally adapted to receive an extension handle 2 via a connector 22. Alternatively, the actuating device 40 can be arranged on the housing 1. The metering reservoir 16 is optionally attached removable on the housing 1, for example, via of a thread assembly.

[0048] In an alternative modality, accommodation 1 is not configured to be safe by a user but instead is attached to a belt or contained in a backpack, or similar, which is used by the user. Alternatively, housing 1 is adapted to be removable fastened to a frame. In such a case, the actuation device 40 remains operatively associated with the dosing portion of the needle-free injection device when in use.

[0049] The actuation device 40 comprises a gas-tight chamber 4 with a piston and rod assembly 32 alternately disposed within the chamber 4 and movable between a front position and a rear position. The term gas-tight chamber, as used herein, generally refers to a chamber that has an alternating piston and rod arrangement therein. The gas-tight chamber is adapted to minimize or prevent the escape of a pressurized gas, or mixture of gases, in order to keep the gas, or mixture of gases, contained therein in a pressurized state.

[0050] The piston and stem assembly 32 includes a piston portion 60 and a stem portion 30. The shape of piston 60 generally corresponds to the shape of the interior of the gas-tight chamber 4. In a specific embodiment of the present invention, as shown in Figures 3A, 3B and 3C, the gas-tight chamber 4 is substantially cylindrical having an interior with a generally circular cross section. The piston 60 of the piston and stem assembly 32 is generally disk-shaped and the circumference of the piston 60 defines an outer edge 62 that is in contact with the inner surface 64 of the chamber

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12/39 gas-tight 4 so that piston 60 defines an extension portion E and a compression portion C within the gas-tight chamber 4. The circumference of piston 60 can be defined by a sealing member 66, which it may be an o-ring. The piston 60 further comprises a hollow passage (not shown) for fluid communication between the extension portion E and the compression portion C. The passage is dimensioned to allow rapid movement of the piston and stem assembly 32 within the chamber 4 from the rear to the front position. This configuration is similar to that observed in springs or gas-charged dampers, in which a passage (s) inside the piston is dimensioned to reduce or reduce the displacement of the piston and rod assembly inside the chamber.

[0051] In one embodiment, piston 60 has a generally circular passage through it that has a diameter that is approximately one third (a ratio of 1: 3) of the diameter of piston 60. The skilled person will appreciate that the ratio of circular passage diameter for piston diameter 60 can be varied. If, for example, the ratio is a 1: 6, thereby having a smaller passage diameter compared to the 1: 3 ratio mentioned above, the speed of the piston and rod assembly 32 would be decreased. This decrease in speed would allow the use of a gas charge, which would otherwise be used for a larger animal or humans, to inject a smaller animal or human. In contrast, as the ratio approaches 1: 1, the speed of the piston and stem assembly 32 would be increased, compared to the aforementioned 1: 3 ratio. In such a 1: 1 configuration, the gas-tight chamber 4 is constructed of a material strong enough to ensure that the piston and rod assembly 32 does not break the end of the chamber 4 when moving to the front position.

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13/39 [0052] The stem 30 of the piston and stem assembly 32 is disposed inside the chamber 4 and through the opening 68 in the chamber 4. The interaction of the stem 30 with a sealing means 70 positioned around the opening 68 of the chamber 4 provides a seal in order to minimize or prevent leakage of the gas charge from the chamber 4. In a specific embodiment, the sealing means 70 is an o-ring.

[0053] According to another embodiment of the invention, the chamber 4 is provided with reinforcement members 72 positioned adjacent to the opening 68. The reinforcement members 72 act to provide support for the walls of the chamber 4 and for the rod 30.

[0054] Chamber 4 contains a gas charge to force the piston and stem assembly 32 to its front position (as shown in Figure 3A). The term gas charge, as used herein, generally refers to a pressurized inert gas, or a pressurized mixture of more than one type of inert gas, contained within the gas-tight chamber 4. Examples of inert gases suitable for Use in the actuation device of the needle-free injection device of the present invention includes, but is not limited to, nitrogen, carbon dioxide, helium, neon, argon, krypton, xenon, and mixtures thereof. The selection of the inert gas will depend on several factors, which include: application, cost, ease of use, etc. In practice, empirical tests can be used to confirm the suitability of a selected gas or gas mixture. In such tests, suitability can be determined by measuring the depth of injection achieved compared to the depth when the injection is performed with a traditional needle (an industry standard) and / or the recommended depth of drug placement by the drug manufacturers . Advantageously, the inert gas is nitrogen. Conventional means for introducing a gas charge into chamber 4 can be used and are known to those skilled in the art.

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14/39 in the art.

[0055] The pressure of the gas charge inside the gas-tight chamber 4 is greater than that of the surrounding atmospheric pressure, thus forcing the piston and rod assembly 32 to the front position (as shown in Figure 3A). Finally, the selection of the appropriate gas pressure and type of gas will depend on the application of the injection device. Advantageously, the pressure of the gas charge inside the gas-tight chamber is selected so that the medicine is expelled with a force of 100 N to 5000 N. As with certain needle-free injection devices currently used, the force generated can be adjusted , for example, in 50 N increments (for example, 100 N, 150 N, 200 N ... 4550 N, 5000 N). However, it will be clear to those skilled in the art that any force between 100 N and 5000 N can be selected depending on the force required to pierce the subject's skin. The force can be adjusted by adjusting the pressure of the gas charge.

[0056] As the piston and stem assembly 32 is moved from the front to the rear position, the pressure of the gas acting to force the piston and stem assembly 32 forward increases. The repulsive force of the compressed gas on the piston and rod assembly 32 is related to the pressure of the gas charge and the surface area of the piston and rod assembly 32 exposed to the compressed gas.

[0057] According to an embodiment of the present invention an actuation device 40 includes a lubrication means to lubricate the interaction of the piston and rod assembly 32 with the interior of the chamber

4. The lubrication medium can also improve the sealing interaction between the stem 30 of the piston assembly and stem 32 and the o-ring 66 at the opening 68 of the chamber 4. The loss of the gas charge and / or the lubrication medium of chamber 4 is minimized or prevented due to the sealing interaction of stem 30 and sealing member 70. It will be appreciated

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15/39 by those skilled in the art that the nature of the lubrication medium, if present, depends on the general application of the actuation device 40, and the conditions under which it is used. In one example, the volume and viscosity of the lubrication medium is selected so that the movement of the piston and rod assembly 32 from the rear position to the front position within the gas-tight chamber 4 is not significantly dampened by the presence of the lubrication. For example, a small volume of light oil is less likely to cushion the displacement of the piston and stem assembly 32 than a larger volume or heavier oil. In contrast, if the person skilled in the art requires the speed of the piston and rod assembly 32 to be dampened (which may be necessary if, for example, a high pressure gas charge is to be used), greater volume or an oil more viscous is used.

[0058] When the actuation device is installed in a needle-free injection device, the piston and stem assembly can be slightly compressed, as shown in Figure 3B. This slight compression helps in the distribution of the lubrication medium around the piston and rod assembly 32.

[0059] In an embodiment of the present invention, the actuation portion and the dosage portion of the injection device are directly attached to each other. In this embodiment, clearance coupling 13 connects the piston of the piston assembly and stem 32 to the plunger

15. The clearance coupling 13 maintains a clearance distance X between the stem 40 and the plunger 15 when the piston and stem assembly 32 is in the rear position. The clearance coupling 13 is removably attached to the stem 30 and is in sliding coupling with the plunger 15. As shown in Figures 4A, 4B and 4C, the plunger 15 is mounted through an opening in the clearance coupling 13, so that the plunger 15 is received sliding inside one end of the

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16/39 clearance coupling 13. The clearance coupling 13 is attached at the opposite end to the connector 12, which is in turn connected to the stem 30. In an alternative embodiment, the clearance coupling 13 is attached directly to the assembly piston and stem 32 and no connector is required. It will be apparent to those skilled in the art that the clearance coupling 13 can be connected to the stem 30 and the plunger 15 in a variety of ways, as long as the clearance distance X is maintained between the piston and stem assembly 32 and the plunger 15 when the piston and stem assembly 32 is in the rear position. This configuration results in a direct impact of the piston 15 by the piston and rod assembly 32 when it is released for movement by said gas charge to its forward position.

[0060] In some cases, it may be desirable that the actuation portion of the injection device is located away from the dosing portion (see Figures 8 and 9). This can be advantageous, for example, if the actuation device is heavy and, therefore, it is easier for a user to carry the actuation portion on his waist, on his back, slung over one shoulder, or similar, on a remote portion 202 In this embodiment, the manual portion 200 contains the dosing chamber 16, the plunger 15 and the nozzle 17. In such a configuration of the needle-free injection device, a transfer means 100 for transferring the force generated by the movement of the piston assembly and stem 32 for said plunger 15 is incorporated in the general device. This configuration results in an indirect impact of the piston 15 by the piston and rod assembly 32 when it is released for movement by said gas charge to its forward position. Specifically, the activation of the trigger causes the piston and rod assembly 32 to be released for movement by said gas charge to the forward position thereby imparting a force to the transfer medium 100, which in turn transfers the force to the plunger 15. In such an example 870170056992, of 08/09/2017, p. 23/55

17/39 plo, the clearance coupling 13 connects the transfer medium 100 to the plunger 15 (Figure 8), or the piston 30 of the piston and rod assembly 32 to the transfer medium 100 (Figure 9). The clearance coupling 13 maintains the clearance distance X between the transfer medium 100 and the plunger 15 (Figure 8), or between piston 30 and transfer medium 100 (Figure 9), respectively, when the piston assembly and stem 32 is in the rear position. The transfer means 100 may be in the form of, for example, a closed hydraulic hose, a flexible multi-connection cable / shaft contained within a wrap, or the like.

[0061] The appropriate clearance distance X is selected to maximize the speed of the piston and rod assembly 32 after firing the device and before direct or indirect impact with the plunger 15. This, in turn, maximizes the force available for the impact of the liquid on the orifice end of the device. This impact force is important for the operation of the device, as it provides the opening for the medication to pass through the skin and subcutaneous tissue. The clearance distance X also allows the injector to perform injections in large animals using relatively low pressures because the impact required to pierce the skin and subcutaneous tissue is much greater than the pressure required to inject the remaining dosage of the drug into the tissue wanted. This makes the injector safer and much less painful for the subject receiving an injection compared to conventional needle-free injection devices. To draw a comparison, when fired, an injector that operates with constant pressure during an injection pierces the skin and subcutaneous tissue and applies the liquid to be injected using the same pressure. If the user moves or slides the orifice end of the device during this process the meat the subject can be cut, as with a scalpel, thus potentially causing severe

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18/39 injuries. By including the gas coupling 13, the pressure is delivered in a peak formation where, on impact, the pressure increases to the desired level to pierce the tissue, but falls to perform the rest of the injection (see Figure 10).

[0062] If the clearance distance X is too small, the piston and stem assembly 32 is unable to reach maximum speed, the impact is reduced and the force in the hole available for drilling is less. If the clearance distance X is increased, very little effect on the impact results due to the fact that both the maximum speed has already been reached and therefore the maximum force has been reached at the orifice end.

[0063] In an embodiment of the present invention, the clearance distance X is a fixed distance. In one example, the clearance distance is 9.52 mm (3/8 inches). In an alternative embodiment, the clearance coupling is adjustable by the user so that the clearance distance can be varied depending on the application of the device. In another alternative embodiment, the clearance coupling is integral with the stem 30.

[0064] In operation, as the piston and stem assembly 32 moves from the rear to the front position they travel by the clearance distance X before the impact end of the stem 30 impacts, or directly (Figures 2, 4 and 5) or indirectly, through the transfer medium (Figures 8 and 9), the rear end of the plunger 15. The plunger 15, in turn, moves from its rear position to its front position within the metering reservoir 16 in order to expel a liquid from the metering reservoir 16 through the nozzle 17.

[0065] The actuating device 40 of the needle-free injection device of the present invention further comprises a means for moving the piston and stem assembly 32, against the gas load within the gas-tight chamber 4, from its front position to the your position

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19/39 rear. By using this means to move, a user is able to load the injection device in order to make it ready for injection. The means for moving the piston and rod assembly 32 can be a motorized or manual means.

[0066] According to a specific embodiment of the present invention the means for moving the piston and rod assembly 32 is a motorized means. Such a motorized medium may include DC (optionally rechargeable) and / or AC power supplies. In one example, the motor will be mounted removably in its own assembly or inside a support.

[0067] According to an alternative embodiment of the present invention the means for moving the piston and rod assembly 32 is a manual means. An example of such a manual means is shown in Figure 5. Handle 3 is hingedly connected to housing 1 of the needle-free injection device and is pivotable from a first closed position (as shown in Figure 5A) to a second open position (as shown in Figure 5B). The push rod 50 is hinged to the handle 3. The push rod 50 can be fixed in length or can be configured to allow a variation in length. For example, the push rod 50 shown in Figure 5, includes a threaded member 10 received within a threaded receiving body 8. The length of the push rod 50 is decreased or increased by screwing or unscrewing the threaded member 10 respectively. receiving body 8.

[0068] Figures 8 and 9 show an injection device of the present invention comprising a remote portion 202 that is distantly related to the manual portion 200. According to this embodiment of the present invention the means for moving the piston and rod assembly 32 it is a motorized or manual medium, as described above. Furthermore, the motorized or manual medium may be stuck or in the

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20/39 remote portion 202 or manual portion 200.

[0069] In operation, the movement of the handle 3 from the first closed position (Figure 5A) to the second open position (Figure 5B) places the push rod 50 in coupling with the actuation member

11. The actuating member 11 is operatively associated with the rod 30 of the piston and rod assembly 32 so that the movement of the actuating member 11 causes a corresponding movement of the piston and rod assembly 32 in order to move it, against the gas load, from its front position to its rear position. This movement loads or acts on the injection device.

[0070] In the specific embodiments of the present invention shown in Figures 1, 2, 3, 4, 5, 6, 7 and 9, the actuating member 11 is attached to the clearance coupling 13 through the connector 12 and the connector 12 is attached removable on the stem 30. In Figure 8, the actuating member 11 and the connector 12 are removably attached to the stem 30 and in the middle to transfer the force 100, which is in turn attached to the clearance coupling 13 through a second connector 212. The movement of handle 3 from the first closed position to the second open position results in the push rod 10 engaging a tooth 80 in the actuating member 11. The movement of handle 3 from the second open position back to the first closed position transfers a driving force for the actuating member 11 which, in turn, moves the piston and rod assembly 32, through the movement of the connector 12, from its front position to its rear position. In an alternative embodiment, the actuation member 11 is directly connected to the piston and stem assembly 32.

[0071] Once in the rear position, the piston and stem assembly 32 is held in place by a trigger. The trigger is a mechanism that holds the piston and stem assembly 32 in the rear position and is user-activated to allow the piston and stem assembly 32 to be

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21/39 released from its rear position to move to the front position due to the pressure generated by the compressed gas charge.

[0072] According to an embodiment of the present invention, the activation of the trigger user causes the disengagement of the push rod 50 from the actuation member 11. In the specific embodiment shown in Figure 2, the trigger comprises a firing lever 5 which has a first end 92 and a second end 94 and being pivotable around the hinge member 24. The firing lever 5 is connected at the first end 92 to the push rod 50. When a downward force is exerted on the second end 94, for example by button 7, the trigger trigger 5 pivots around the hinge member 24 and the first end 92 is raised, thus causing the push rod 50 to disengage from the actuation member 11. Once the push rod 50 is decoupled from the actuating member 11, the forward movement of the piston and stem assembly 32 is compromised, that is, there is nothing to stop or slow down the movement of the piston assembly and has 32 from its rear to its front position in response to the compressed gas load. In the event that the device comprises a remote portion 202 and a manual portion 200, activation of the trigger user may be effected either in the remote portion 202 or in the manual portion 200 or both. As shown in Figures 8 and 9, lever 220 is a conventional finger trigger within manual portion 200 and is connected to remote portion 202 via trigger cable 206. A non-limiting example of trigger cable 206 is a steel cable , optionally contained sliding inside a plastic housing. It will be apparent to those skilled in the art that various types of cable are suitable for use as the trigger cable 206.

[0073] In contrast to the injection device of the present InPetition 870170056992, of 09/08/2017, p. 28/55

However, previous injectors required that the trigger be pressed during the entire course of the injection. In such injectors, if the user stops pressing the trigger, the injection process stops. Therefore, these prior devices may result in an incomplete administration of the desired dose of the drug due to a user error in using the trigger.

[0074] In accordance with an embodiment of the present invention, the injection device includes a trigger guard 23, which is designed to minimize or eliminate the possibility of unintentional firing of the actuated device.

[0075] According to another embodiment of the present invention, the injection device includes a safety lock to keep the handle 3 in the first closed position until it is unlocked for use. The security lock may comprise a movable hook that faces downwards on the underside of the handle 3 that interacts with a hook that faces upwards on the outer surface of the housing 1. By moving the hook that faces downwards, the security lock is released and the handle 3 can be moved to its second open position. Alternatively, the security lock may comprise a slot in the handle 3 to receive a pressable button on the outer surface of the housing 1. By pressing the button, the security lock is released and the handle 3 can be moved to its second open position. [0076] Figures 11-21 and 22-25 show needle-free injection devices in accordance with the alternative embodiments of the present invention, which include a manual or motorized means for moving the piston and rod assembly from its forward position to the its rear position. In each case, the device includes a means for transferring and / or amplifying the force applied to the injection device to load the actuation device. According to a specific embodiment of the present invention, the means for transferring and / or amplifying

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23/39 the applied force comprises a set of gears, examples of which are shown in Figures 11-21 and 22-25. Such a set of gears provides a mechanical advantage to facilitate loading of the actuation device. The actuation device of the needle-less injectors shown in Figures 11-21 and 22-25 comprises an actuation member operatively associated with the rod of said piston and rod assembly. The manual or motorized means for moving the piston and rod assembly transfers a force to a gear set, which in turn transfers, and optionally amplifies, the force for the actuating member to move the piston and rod assembly from the forward position to the rear position.

[0077] As discussed above, the actuation device 40 of the needle-free injection device of the present invention further comprises a means for moving the piston and stem assembly 32 against the gas charge within the gas-tight chamber 4 of its front position to your rear. The means for moving the piston and rod assembly 32 can be a motorized or manual means.

[0078] Referring to Figures 11-21, the actuating device 40 is disposed within a guide tube 348, which is connected to the metering reservoir 16 via a connector 390. The connector 390 is generally an open-ended cylinder which has a first end, for removable fixing to guide tube 348, and a second end, for removable fixing to dosing reservoir 16. Optionally, connector 390 is removably attached to guide tube 348 via a threaded connection. Similarly, connector 390 is optionally attached removably to the metering reservoir 16 via a screw connection.

[0079] In an alternative embodiment, connector 390 is attached removably to the dosing reservoir 16 via a mechanism

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24/39 quarter-turn release. In such a quarter-turn release mechanism, connector 390 further includes two pins (not shown) that protrude from the inner surface of connector 390. In this example, the metering reservoir 16 includes a generally L-shaped groove. on its outer surface. The protruding pins and the generally L-shaped groove are configured to match sliding with each other when the dosing reservoir 16 is inserted into connector 390, and rotated, so that the pins follow the generally L-shaped groove. quarter-turn release mechanism, a drum corrugated spring 400 is disposed between connector 390 and dosing reservoir 16 in order to force connector 390 and dosing reservoir 16 apart, and prevent free rotation of connector 390 and the dosing reservoir 16.

[0080] The plunger 15 is disposed within the metering reservoir 16 and is removably attached to the clearance coupling 13. In one example, the plunger 15 is attached to the clearance coupling 13 by a threaded screw. In another example, the plunger 15 is attached to the clearance coupling 13 by a quarter-turn mechanism. The clearance coupling 13 is removably attached to piston 30 of the piston and stem assembly 32. An idler pulley 316 is mounted slidably within the guide tube 348 and is attached to the clearance coupling 13. Loading [0081] As described above, the movement of the piston and stem assembly 32 from its front position to its rear position carries the injection device. In use, the injection device shown in Figures 11 to 21, is loaded by moving the idler pulley 316 from a front to a rear position, which in turn moves the piston and stem assembly 32 from its front position to its rear. Consequently, in the device shown in Figures 11Petition 870170056992, of 08/09/2017, p. 31/55

25/39

21, the idler pulley 316 is serving as an acting member, as described above.

[0082] As noted above, a gear set provides a mechanical advantage to facilitate loading the actuator. According to an embodiment of the present invention, an actuation force is applied by the user in the manual medium to move the piston and rod assembly 32. In the specific embodiment shown in Figures 11 to 21, the manual medium comprises a loading handle 300, which is attached to a support 364, which is in turn attached to the main shaft 302 by a ratchet mechanism 311. The loading handle 300 is pivotal from a first closed position (as shown in Figures 11, 16 , 17, 18 and 19) to a second open position (not shown). The main shaft 302 is mounted through the gear end 308, and includes a first end 301 and a second end 302. When the loading handle 300 is pivoted, the loading handle 300 and the support 364 rotate the main shaft 302.

[0083] The ratchet mechanism 311 and the claw 313 that couples the ratchet mechanism 311 are configured to allow the main shaft 302 to rotate when the loading handle 300 is moved from the first closed position to the second open position, and to prevent the main shaft 302 rotates when the loading handle 300 is moved from the second open position to the first closed position. Other suitable ratchet mechanisms will be well known to those skilled in the art and can be incorporated into the needleless injection device of the present invention.

[0084] A main gear 310 is attached to the first end 301 of the main shaft 302; a main pulley 312 is attached to the second end 303 of the main shaft 302. Both main gear 310 and main pulley 312 rotate with the shaft

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Main 26/39 302. A cable 314 passes around the idler pulley 316, and includes a first end 315 attached to the main pulley 312 and a second end (not shown) attached to the main gear end 308. The cable 314 is constructed of steel and / or other suitable material (s).

[0085] The gears are operable to move the idler pulley 316 from a front position to a rear position, and thereby move the piston and stem assembly 32 from its front position to its rear position.

[0086] The main pulley 312 is rotatable from a first unwound position to a second rolled position. As the main pulley 312 is rotated from the first unwound position to the second wound position, the cable 314 winds around the main pulley 312 and pulls the idler pulley 316, thereby moving the piston and stem assembly 32 from its front position to its rear position, against the gas load inside the gas-tight chamber 4.

[0087] In this example, the trigger is a firing mechanism that retains the piston and stem assembly 32 in its rear position.

[0088] A trigger pivot arm 328 is pivotable about a secondary axis 332 from a locked position to an unlocked position. A firing gear 326 is mounted on the trigger pivot arm 328; when the trigger pivot arm 328 is in the locked position, the trigger gear 326 is in a gear relationship with the main gear 310. In the locked position, the trigger gear 326 rotates as the main gear 310 rotates.

[0089] A drive gear 330 is mounted on the secondary shaft 332, and is also in gear with the trigger gear 326; according to the dispaPetition gear 870170056992, from 08/09/2017, p. 33/55

27/39 ro 326 rotates, drive gear 330 rotates.

[0090] A one-way clutch (not shown, but generally indicated at position 336) allows the secondary shaft 332 to rotate when the loading handle 300 is moved from the first closed position to the second open position. Thus, the unidirectional clutch 336 retains the load of the actuating device 40 preventing the main shaft 302 and the secondary shaft 332 from rotating when the loading handle 300 moved from the first closed position to the second open position.

[0091] A repeated movement of the loading handle 300 from the first closed position to the second open position, and back, results in the continuous winding of the main pulley 312, and the movement of the piston and rod assembly 32 to the rear position, against the gas charge inside the gas-tight chamber 4.

[0092] The loading of the actuation device 40 continues until the desired load is achieved. In one example, a dosing ring (not shown) is used to adjust the desired load. In this example, the dosing ring is positioned on a guide tube 348 that can be locked in place. The dosing ring is adjustable by the user to adjust the extent to which the piston and stem assembly 32 can be pulled back; therefore, the dosing ring is adjustable by the user to determine the amount of medication that is finally sucked into the injector for a subsequent injection. The dosing ring can be determined to include a wide range of loads, and thus injection volumes. In one example, the dosing ring is adjustable over a volume range between approximately 0.01 cm ³ to approximately 5 cm ³ .

[0093] When the trigger pivot arm 328 is moved to the unlocked position, firing gear 326 pivots away from main gear 310, allowing the gear

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28/39 main 310 and main axis 302 rotate to allow the main pulley 312 to move from the second wound position to the first unwound position. The movement of the main pulley 312 from the second rolled-up position to the first unwound position allows the piston and rod assembly 32 to move from its rear position to its front position, due to the pressure generated by the compressed gas charge.

[0094] The trigger pivot arm 328 is operatively connected to the drum trigger 356 or finger trigger 354 via a series of trigger levers and a trigger rod. The first trigger lever 338 is hinged to the trigger hinge arm 328 and the second trigger lever 340. The second trigger lever 340 is hinged to the hinge bracket 380. The second trigger lever 340 includes a slot 366. The third trigger lever 342 is hinged to the main gear end 308, on the hinge bracket 368. The first end 343 of the third trigger lever 342 is slidably attached to the second trigger lever 340 in the slot 366; the second end 345 of the third trigger lever 342 is attached to the fourth trigger lever 344. The fourth trigger lever 344 is hinged to the third trigger lever 342 in the hinge bracket 370, and is attached to the first end 307 of the shank. main trigger 306.

[0095] The main trigger rod 306 is slidably mounted via trigger rod guides 346, which are attached to the guide tube 348. The main trigger rod 306 is movable between a front position and a rear position, in the front, the trigger pivot arm 328 is in the locked position; in the rear position, the trigger pivot arm 328 is moved to the unlocked position. A 350 trigger finger joint has a first

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29/39 end that is attached to the main trigger rod 306 and a second end that is attached to the finger trigger 354. The drum trigger 356 is mounted sliding over the reservoir 16. The drum spring 352 forces the drum trigger 356 away from the second end 309 of the main trigger rod 306. The needle-free injector can be performed using the barrel trigger 356 or the finger trigger 354.

[0096] Using the barrel trigger 356, the nozzle 17 is pushed over the body to be injected with sufficient force to move the barrel trigger 356 against the drum spring 352 so as to contact or move the main trigger rod 306 from your front position to your rear position.

[0097] Using the finger trigger 354, moving the finger trigger 354 from a forward position to a rear position causes the finger trigger hinge 350 to move the main trigger rod 306 from its forward position to its position rear.

[0098] The movement of the main trigger rod 306 from its front position to its rear position causes the fourth trigger lever 344, the third trigger lever 342, the second trigger lever 350 and the first trigger lever 358 act to move the trigger pivot arm 328 from the locked position to the unlocked position. As discussed above, movement of the trigger pivot arm 328 to the unlocked position allows the main gear 310 and the main shaft 302 to rotate to allow the main pulley 312 to move from the second wound position to the first unwound position. . The movement of the main pulley 312 from the second rolled-up position to the first unwound position allows the piston and rod assembly 32 to move from its rear position to its front position, due to the pressure generated by the compressed gas charge.

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30/39 [0099] After the injection, a spring (not shown) forces the finger trigger 350 from its rear position to its front position. The movement of the finger trigger 350 to the front position results in the movement of the main trigger rod 306 from its rear to its front position, and the movement of the trigger pivot arm 328 from its locked position to its unlocked position. The user is now able to repeat the loading process.

[00100] Alternatively, the drum trigger 356 is forced from its rear position to its forward position by the drum trigger spring 352. A mechanical spring between trigger pivot arm 328 and the first trigger lever 338 (not shown) pulls these pieces together, thereby moving the trigger pivot arm 328 from the released position to the locked position.

[00101] A trigger safety is optionally included. In this mode, trigger safety 304 is movable from a locked position to its unlocked position. When the loading handle 300 is moved from the first closed position to the second open position, the main shaft 302 rotates and causes the trigger guard 304 to move from an unlocked position to its locked position. In the locked position, trigger safety 304 prevents the main trigger rod 306 from moving to its rear position. The trigger guard 304 is hinged to the main gear end 308, and has two springs (not shown) that force trigger guard 304 into the locked position. The trigger position 304 moves from the locked position to the unlocked position when the loading handle 300 is moved to its first closed position. The ratchet mechanism 311 and the claw 313 act on the trigger safety 304 so as to allow the main trigger rod 306 to move to its rear position.

[00102] The needle-less injector shown in Figures 11-21 can

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31/39 can also be operated using a motorized means for loading. In the case of motorized loading, the loading handle 300 can remain in place or be removed. If the loading handle 300 remains in place, a rack mechanism (not shown) is included and allows normal operation of the injector by the 360 gear motor. In addition, if the loading handle 300 is present, trigger safety 304 is deactivated using a safety deactivation cover (not shown).

[00103] According to an embodiment of the present invention, the 360 gear motor is a DC gear motor which is powered by a battery, such as a rechargeable battery. Optionally, the battery is located inside the 358 battery holder. A user activates the 360 gear motor using a lever switch (not shown), which allows electricity from the battery to flow to the 360 gear motor. gear 360 spins a pinion gear 362, which spins a crown gear 334. Secondary shaft 332 spins drive gear 300 (as described above), which spins trigger gear 326. Main gear 310 rotates main pulley 312 , which winds the cable 314, thereby moving the piston and rod assembly 32 from the front to the rear position.

[00104] In this modality, the dosing ring (not shown) includes an electric limit switch (not shown), which once reached by the clearance coupling 13 and the piston and rod assembly 32, interrupts the flow of electricity to the 360 gear motor, thereby stopping loading. The load is maintained by the same one-way clutch 336 on the secondary axis 332, as described for manual loading.

[00105] Triggering is carried out in the same way as described in manual loading, using either the 356 drum trigger or the gatiPetição 870170056992, from 08/09/2017, pg. 38/55

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Finger eye 354.

[00106] Once the piston and stem assembly 32 has returned to the front position, a second electric switch (not shown) is activated, which allows the 360 gear motor to turn on and reload the unit.

[00107] A third electric key (not shown) is mounted on the 354 finger trigger, which acts as a security key. The 354 finger trigger must be in its forward position (or released from any pressure or tightness) for the 360 motor to restart. This is to ensure that the trigger gear 326 and main gear 310 are coupled before the gear motor 360 starts.

[00108] Figures 22-25 show a needle-less injector according to another embodiment of the present invention. The injector shown in Figures 22-25 also includes a set of gears to transfer and / or amplify an actuation force applied to the injector to move the piston and rod assembly against the gas load. The gear set is operatively associated with either the manual means or the motorized means to move the piston and stem assembly in order to provide a mechanical advantage to facilitate loading the actuator. The injector shown in Figures 22-25 also includes an actuating member operatively associated with the rod of said piston and rod assembly. Hereby, said manual means or said motorized means transfers a force to said gear set which transfers the force to said actuating member to move said piston and rod assembly from the front to the rear position.

[00109] Referring to Figures 22-25, the housing 1 is removably connected to the reservoir 16. The actuating device 40 is disposed inside the guide tube 348 in the housing 1. A union connector

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33/39

502 is removably attached to the guide tube 248 and acts as a clearance coupling. The piston and rod assembly 32 of the actuation device 40 is removably attached to the guide tube 348. The piston 15 is slidably disposed within the reservoir 16 and is slidably attached to the coupling coupler 502. A gear rack 504 is attached to the surface outer of the guide tube 348, and is slidably disposed within a slot 507 of the housing 1.

[00110] As described above, the movement of the piston and rod assembly 32 from its front position to its rear position loads the actuation device 40. In the device shown in Figures 22 to 24, the injector is loaded by moving the rack of gear 504 from a front to a rear position, which in turn moves the piston and rod assembly 32 from its front position to its rear. Consequently, the 504 gear rack is serving with an actuating member.

[00111] According to an embodiment of the present invention, the gear motor 360 rotates pinion gear 362, which rotates crown gear 334. Crown gear 334 is attached to a first end of shaft 506 and gear 508 is attached at the second end of the axis 506; gear 508 rotates as crown gear 334 rotates. Shaft 506 is mounted on gear support 509, which is secured in housing 1.

[00112] Gear 508 spins crazy gear 510, which spins composite gear 512. Composite gear 512 includes an outer gear 514 and an internal gear 516. Crazy gear 510 couples swivel to external gear 514. Internal gear 516 swivels loading gear 520. Rotating composite gear 512 turns loading gear 520.

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34/39 [00113] Loading gear 520 includes a first gear 518 and a second recessed gear (not shown, but generally indicated by the line denoted by number 522). The loading gear 520 is pivotally secured to the clutch upright 540; the clutch upright 540 is hingedly hinged in housing 1 on the mounting bracket 542. Loading gear 520 is movable between a loading position and a releasing position. In the loading position, the first gear 518 of the loading gear 520 engages the gear rack 504 and is operable to move the gear rack 540 from its front to its rear position, thereby moving the piston assembly and stem 32 against from the front to the rear position, and loads the actuating device 40. The second recessed gear 522 couples swivelly to the locking gear 524, which is attached to the unidirectional clutch 336.

[00115] One-way clutch 336 and locking gear 524 allow loading gear 520 to rotate when moving gear rack 504 from its front position to its rear, and do not allow loading gear 520 to rotate in order to move the gear rack 504 from its rear to its front position. Thus, the unidirectional clutch 336 retains the load of the actuating device 40.

[00116] The loading of the actuation device 40 continues until the desired load is achieved. In one example, the dosing ring 526 is used to adjust the desired load. In this example, the dosing ring 526 is positioned on the housing 1 in a position determined by the user, and can be locked in place. The dosing ring 526 includes a guide 528 for receiving the rack of

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35/39 gear 504. Guide 528 includes gear teeth (not shown) on the inner surface that mate with gear rack 504. When dosing ring 526 is locked over housing 1 and gear rack 504, the extent to which the gear rack 504 and the piston and rod assembly 32 can be pulled back is determined by the user; therefore, the dosing ring is adjustable by the user to adjust the amount of medication that is finally sucked into the injector for a subsequent injection. The dosing ring can be determined to include a wide range of loads, and thus injection volumes. In one example, the dosing ring is adjustable over a volume range between approximately 0.01 cm ³ to approximately 5 cm ³ .

[00117] When loading gear 520 is moved from its loading position to its release position, loading gear 520 decouples gear rack 504, allowing gear rack 504 to move from its rear position to its forward position.

[00118] In this example, the trigger is a trigger mechanism that retains the piston and stem assembly 32 in its rear position.

[00119] Loading gear 520 is operatively connected to drum trigger 356 or finger trigger 354 by trigger release 532. Trigger release 532 is attached to clutch bracket 540 and is operable to move loading gear 520 between its loading position and its release position. In the example in Figures 22-24, dosing ring 526 includes a trigger handle 530, which is configured to releasably engage trigger release 532. When gear rack 504 has been moved to its rear position, the gatiPetição 870170056992, of 08/09/2017, p. 42/55

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Iho 530 couples trigger release 532. After attaching trigger handle 530 to trigger release 532, loading gear 520 is moved from its loading position to its release position. Consequently, the load within the actuating device 40 is held in place by attaching the trigger handle 530 to the trigger release 532.

[00120] The actuation of the needle-less injector is performed using the drum trigger 356 or the finger trigger 354. In each case, the actuation is achieved by moving the trigger release 532 in order to disengage the trigger handle 530 from the release of trigger 532, thereby allowing gear rack 504 to move from its rear position to its front position. Using the finger trigger 354, pressing the finger trigger 354 causes the trigger handle 530 to disengage from the trigger release 532. Using the barrel trigger 356, the nozzle 17 is pushed over the body to be injected with sufficient force to move the drum trigger 356 against the drum spring (not shown) to cause the trigger handle 530 to disengage from the trigger release 532. [00121] In an alternative embodiment, the needle-less injector shown in Figures 22- 24 is adapted to be suitable for manual loading. In the case of manual loading, the 360 gear motor is not used. In contrast, a loading handle and a ratchet mechanism (not shown) rotate gear 506 directly or indirectly. In the case of indirect rotation of gear 506, a chain gear is optionally used to connect the loading handle and the ratchet on gear 506. Loading and actuation are carried out as described above.

[00122] It will be clear to the person skilled in the art that various gear and gear arrangements can be used in one

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37/39 gear set to increase the mechanical advantage for loading the actuation device 40. For example, a gear train that consists of several gears that act on each other can drive a rack and pinion, which acts directly or indirectly on the piston and rod assembly 32 to move the piston and rod assembly to its rear position. A planetary gearbox can be used to act directly or indirectly on the piston and stem assembly 32, in a similar way. Similarly, a planetary gearbox and rack system can be used. The use of a worm gear drive is another alternative. Any combination or assembly of any suitable individual gear option can increase the mechanical advantage several times, thereby reducing the force to load the actuation device 40. The addition and use of such gear trains makes it easier for users to load the actuation device 40.

[00123] As would be readily appreciated by someone skilled in the art, the positioning of the mouthpiece against the subject will depend on a number of factors, which include, but are not limited to, the species and region of the body to be injected, the age of the subject to being injected, and the pressure of the gas charge. For example, certain animal species will have skin that is more difficult to pierce than others. This is due, in part, to species differences in skin thickness. In addition, members of a specific species will have regions of the body that are more or less difficult to inject. The age of the animal or human can also have an effect on the ease of injection, as the thickness and roughness of the skin may vary with age. For example, in some species, a younger individual (for example, a newborn or a child) will have skin that is more readily injectable than

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38/39 than an adult individual. Also, in a variety of animals, for example, the regions behind dark circles and in the folds of the limbs will typically be easier to inject. Those regions of the body that are most readily injected will require a lower pressure gas charge compared to a region of the body that is more difficult to inject. Those skilled in the art will appreciate and take into account the various differences in species, body regions and / or ages when selecting the pressure of the gas charge.

[00124] The injection device of the present invention optionally includes a supply reservoir to supply the liquid to the dosing reservoir 16. In a specific, non-limiting example, as shown in Figures 2 and 9, the supply reservoir is a syringe 21 that contains a medicine. In Figure 8 the supply reservoir is a 208 bottle that contains a drug. Syringe 21 and vial 208 are connected to the dosing reservoir 16 by a pipe extension 19 and a check valve

18. The check valve 18 allows unidirectional movement of the medicine from the syringe 24 into the dosing reservoir 16. In these embodiments, the movement of the plunger 15 from the front to the rear position within the dosing reservoir 16 causes a single dose of medication is aspirated from syringe 21 into the dosage reservoir 16.

[00125] According to another aspect of the present invention there is provided a method for using the needle-free injection device for injecting a liquid through the skin of a subject, which can be an animal or a human. The method comprises the steps of (i) providing a needle-free injection device of the present invention that has at least one dose of the liquid to be administered; (ii) actuating the device by moving the piston and stem assembly 32 to the rear position; placing the nozzle 17 against the subject's skin to be injected; and

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39/39 (iii) trigger the actuation device to expel a dose of liquid through the outlet orifice and nozzle 17 and through the subject's skin. [00126] All publications, patents and patent applications mentioned in this Specification are indicative of the level of knowledge of those skilled in the art to which this invention belongs and are incorporated by reference to the same extent as if each publication, patent, or patent application individual was specifically and individually indicated to be incorporated by reference.

[00127] The invention being so described, it will be obvious that it can be varied in many ways. Such variations should not be considered as departing from the spirit and scope of the invention, and all such modifications as would be obvious to someone skilled in the art are intended to be included in the scope of the following claims.

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Claims (15)

1. Needle-free injection device for delivering a medicine under pressure from a dosing reservoir (16) through an outlet orifice (17) of the type comprising a plunger (15) received sliding into the dosing reservoir (16 ) and movable in one direction of the orifice (17) to expel the medication through the orifice (17) comprising an actuation device (40) comprising: (a) a gas-tight chamber (4); (b) a piston and rod assembly (32) received sliding into the chamber (4) and movable between a front position, close to the orifice, and a rear position, still from the orifice; (c) a charge of gas in the chamber (4) to force the piston and rod assembly (32) to the front position; (d) a motorized means for moving the piston and rod assembly (32) against the gas charge to the rear position; and (e) a trigger (354,220) to reliably retain the piston and rod assembly (32) in the rear position, characterized by the fact that the trigger comprises a firing lever (5) having a first end (92) and a second end (94) and being pivotable around a hinge member (24) and connected at the first end of the push rod (50), whereby when a downward force is exerted on the second end (94) of the lever The firing rod (5) articulates around the articulation member (24) and the first end (92) is raised, causing the thrust rod (50) to disengage from the actuation member (11), which is directly connected to the piston and rod assembly (32) so that the piston and rod assembly (32) moves from the rear to the front position, where the activation of the trigger (354,220) causes conPetition 870170056992, 09 / 08/2017, p. 47/55 2/4 together with piston and rod (32) to be released for movement by the gas charge to the front position in order to impact the piston (15) directly or indirectly with a sufficient force to make the piston (15) move in the direction of the orifice (17) to expel the medicine through that of the orifice (17); and in which the gas-tight chamber (4) is adapted to minimize or prevent leakage of the gas charge in order to maintain the gas charge in a pressurized state. 2. Needle-free injection device, according to claim 1, characterized by the fact that the circumference of the piston (60) of the piston and stem assembly (32) defines an outer edge (62) that is in contact with the surface inner (64) of the gas-tight chamber (4) so that the piston (60) defines an extension portion (E) and a compression portion (C) of the gas-tight chamber (4). Needle-free injection device according to claim 2, characterized in that the piston (60) of the piston and rod assembly (32) comprises a passage for fluid communication between the extension portion (E) and the compression portion (C) of the gas-tight chamber (4). Needle-free injection device according to any one of claims 1 to 3, characterized in that the gas charge is a compressed inert gas or a mixture of compressed inert gas. 5. Needle-free injection device according to claim 4, characterized by the fact that the compressed inert gas is nitrogen. 6. Needle-free injection device according to any one of claims 1 to 5, characterized in that it still comprises a lubrication means for lubricating the assembly Petition 870170056992, of 08/09/2017, p. 48/55 3/4 piston and rod (32). 7. Needle-free injection device according to claim 6, characterized by the fact that the lubrication medium is a light oil. Needle-free injection device according to any one of claims 1 to 7, characterized in that it further comprises a clearance coupling (13) connecting the piston rod (30) and piston rod (32) to the piston ( 15), in which the clearance coupling (13) is configured to maintain a clearance distance (X) between the rod (30) and the piston (15) when the piston and rod assembly (32) is in the rear position. 9. Needle-free injection device according to claim 8, characterized by the fact that the clearance coupling (13) comprises: (a) a first end for removable attachment of the clearance coupling (13) to the rod (30); and (b) a second end for sliding coupling with the plunger (15). 10. Needle-free injection device according to any one of claims 1 to 7, characterized in that it further comprises a means for transferring the force generated by the movement of the piston and rod assembly (32) to the piston (15) , whereby activating the trigger causes the piston and rod assembly (32) to be released for movement by the gas charge to the front position thereby printing a force in the middle to transfer the force which in turn prints the force on the plunger (15) is sufficient to cause the plunger (15) to move in the forward direction to expel the medication through the outlet. 11. Needle-free injection device according to any one of claims 1 to 10, characterized by the fact that Petition 870170056992, of 08/09/2017, p. 49/55 4/4 still comprises: (a) a set of gears operatively associated with the motorized medium; and (b) an actuating member (11) operatively associated with the rod (30) of the piston and rod assembly (32), whereby the motorized medium transfers a force to the gear assembly which transfers the force to the actuating member (11) to move the piston and rod assembly (32) from the front to the rear position. 12. Needle-free injection device according to claim 11, characterized by the fact that the motorized medium is a DC power source. 13. Needle-free injection device according to claim 11, characterized by the fact that the motorized medium is an AC power source. Needle-free injection device according to any one of claims 1 to 13, characterized in that the push rod (50) is adjustable in length. 15. Kit for the use of the needle-free injection device as defined in any of claims 1 to 14, characterized by the fact that it comprises: (a) the needle-free injection device; and (b) instructions for its use. Petition 870170056992, of 08/09/2017, p. 50/55 1/25 2/25 FIG 2 3/25 FIG 3 SJj 4/25 ΙΛ CO Ο ro (Μ FIG 4 5/25 FIG 5 6/25 FIG 6 ec 7/25 FIG 7 202 8/25 FIG 8 6? 9/25 FIG 9 10/25 Device pressure standard of the invention FIG 10 11/25 FIG 11 FIG 12 13/25 FIG 13 14/25 FIG 14 15/25 400 FIG 15 356 Z / 9J. Hello FIG 16 17/25 GÇ> ts. 300 FIG 17 I ρο ϊο cn FIG 18 300 13 348 316 3.2 19/25 FIG 19 20/25 gz / vz 22/25 FIG 23 23/25 FIG 24 24/25 <71 522 522 518 520/514 362 344 25/25 FIG 25